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Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Calibra Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02542631
First received: September 3, 2015
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.

Condition Intervention
Diabetes Mellitus, Type 2 (T2DM)
Device: Bolus Insulin Patch (Calibra Finesse)
Device: Insulin Pen (Novo-Nordisk FlexPen®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

Resource links provided by NLM:


Further study details as provided by Calibra Medical, Inc.:

Primary Outcome Measures:
  • Change in A1C, with bolus insulin dosing with Finesse versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Proportion of patients with A1C ≤7.0% at week 24 [ Time Frame: 24 weeks ]
  • Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients) [ Time Frame: 24 weeks ]
  • Change in A1C from baseline to week 44 [ Time Frame: 44 weeks ]
  • Proportion of patients with A1C ≤7.0% at week 44 [ Time Frame: 44 weeks ]
  • Change in A1C from week 24 to week 44 [ Time Frame: 44 weeks ]

Other Outcome Measures:
  • Treatment satisfaction and quality of life [ Time Frame: 24 weeks ]
  • Severe hypoglycemia incidence [ Time Frame: 44 weeks ]

Estimated Enrollment: 280
Actual Study Start Date: August 1, 2015
Estimated Study Completion Date: October 1, 2017
Primary Completion Date: March 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bolus Insulin Patch (Calibra Finesse)
Use of the wearable patch to deliver meal-related bolus insulin dose
Device: Bolus Insulin Patch (Calibra Finesse)
Active Comparator: Insulin Pen (Novo-Nordisk FlexPen®)
Use of the pen device to deliver meal-related bolus insulin dose
Device: Insulin Pen (Novo-Nordisk FlexPen®)

Detailed Description:
Patients sub-optimally controlled on basal insulin (with/without other antihyperglycemic agents (AHAs)) will be randomized 1:1 to either Finesse or pen to initiate bolus insulin dosing and followed for a 44-week intervention period. Patients will have both basal and bolus doses of insulin adjusted throughout the trial, as is clinically indicated, based on an easy to follow insulin dosing algorithm. After the final endpoint evaluation at week 44, patients will crossover to the alternate bolus insulin delivery device for 4 weeks and complete a patient preference survey at week 48.
  Eligibility

Ages Eligible for Study:   22 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of T2DM
  • Treated with basal insulin for ≥ 6 months, with current dose stable for ≥ 6 weeks of ≥ 0.3 U/kg/day, with or without anti-hyperglycemic agents and in whom the Investigator feels advancement from basal to basal and bolus therapy is needed for the patient
  • A1C 7.5-11.0% by central lab value at screening visit
  • Already perform self-monitoring of blood glucose (SMBG) and willing to test blood glucose (BG) over the course of the study
  • Body Mass Index of ≤ 40 kg/m2

Exclusion Criteria:

  • Currently on or has been treated in the past year with insulin regimens that include bolus insulins except the need for insulins in the settings of acute illness or hospitalization
  • History of type 1 diabetes mellitus (T1DM), or diabetic ketoacidosis (DKA), or secondary forms of diabetes such as cystic fibrosis
  • Known hypersensitivity or allergy to insulin-glargine or its excipients or any other insulins
  • Two or more severe hypoglycemic episodes within the prior year
  • Hypoglycemia unawareness defined by history
  • History of proliferative diabetic retinopathy
  • Is currently unstable and/or has moderate-to-severe medical illness in the Investigator's judgment
  • Uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 100 mmHg at screening
  • History of recent major surgery within 6 months, or minor surgery within 3 months (such as appendectomy) prior to screening visit, or a planned surgery during the study period
  • History of bariatric surgery
  • Active chronic infections
  • Women of child-bearing age who are pregnant, planning pregnancy, breast-feeding, or, if capable of pregnancy, are not practicing contraception if heterosexually active
  • Known hypersensitivity to plastics/polymers/adhesives
  • Known difficulties with adherence of adhesives, bandages, or dressings
  • Participated in any research study within the past 30 days
  • Currently participating in another investigational trial
  • Use of short term or chronic systemic steroids within three months of entry into the study or likelihood that same might be required during the conduct of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02542631

  Hide Study Locations
Locations
United States, Arizona
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
United States, California
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
Escondido, California, United States, 92025
Marin Endocrine Care and Research
Greenbrae, California, United States, 94904
National Research Institute - Wilshire
Los Angeles, California, United States, 90057
Diabetes Research Institute Mills-Peninsula Health Service
San Mateo, California, United States, 94401
Encompass Clinical Research
Spring Valley, California, United States, 91978
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
Physicians Research Associates
Lawrenceville, Georgia, United States, 30046
Endocrine Research Solutions, Inc
Roswell, Georgia, United States, 30076
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center PA
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States, 60611
John H. Stroger, Jr. Hospital of Cook County Diabetes Center
Chicago, Illinois, United States, 60612
United States, Iowa
Iowa Diabetes and Endocrinology Research Center
Des Moines, Iowa, United States, 50314
United States, Kansas
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
Great Plains Diabetes
Wichita, Kansas, United States, 67212
United States, Kentucky
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States, 40503
United States, Maryland
Medstar Health Research Institute
Hyattsville, Maryland, United States, 20782
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Park Nicollet Institute International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, New York
SUNY Upstate Medical University
Syracruse, New York, United States, 13210
United States, Ohio
VA Medical Center Cleveland
Cleveland, Ohio, United States, 44106
United States, Tennessee
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States, 37411
United States, Texas
Texas Diabetes & Endocrinology, P.A.- Austin
Austin, Texas, United States, 78749
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230
Baylor Endocrine Center
Dallas, Texas, United States, 75246
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States, 78229
South Texas Veterans Health Care System
San Antonio, Texas, United States, 78229
Consano Clinical Research
San Antonio, Texas, United States, 78258
United States, Utah
Progressive Clinical Research
Bountiful, Utah, United States, 84010
Highland Clinical Research
Salt Lake City, Utah, United States, 84124
United States, Virginia
Danville Internal Medicine
Danville, Virginia, United States, 24541
United States, Washington
Private Practice-Larry Stonesifer
Federal Way, Washington, United States, 98003
Rainier Clinical Research Center
Renton, Washington, United States, 98057
France
Hopital Avicenne
Bobigny, France, 93009
Hopital Saint-Andre
Bordeaux, France, 33000
Hopital Hotel-Dieu Site Harfleur
Le Creusot, France, 71200
Lapeyronie Hospital, University Hospital Montpellier
Montpellier cedex 5, France, 34295
Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications
Paris, France, 75475
CHU de Nantes-Hospital Nord Laennec
Saint-Herblain, France, 44093
GHMP les Portes du Sud
Venissieux, France, 69200
Germany
Diabeteszentrum DO-Diabetologisch
Dortmund, Germany, 44137
BAG Unterm Heilig Kreuz Unterm Heilig Kreuz
Fulda, Germany, 36037
Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.
Mainz, Germany, 55116
United Kingdom
Royal United Hospital, Diabetes & Lipid Research Wolfson Centre
Bath, United Kingdom, BA1 3NG
Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust
Blackburn, United Kingdom, BB2 3HH
Chorley and South Ribble Hospital
Chorley, United Kingdom, PR7 1PP
Ninewells Hospital & Medical School Diabetes Support Unit
Dundee, United Kingdom, DD1 9SY
Forth Valley Royal Hospital Dept. of Diabetes
Larbert, United Kingdom, FK5 4WR
Leicester General Hospital Leicester Diabetes Centre
Leicester, United Kingdom, LE5 4PW
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Calibra Medical, Inc.
Medpace, Inc.
  More Information

Responsible Party: Calibra Medical, Inc.
ClinicalTrials.gov Identifier: NCT02542631     History of Changes
Other Study ID Numbers: VP-00525
Study First Received: September 3, 2015
Last Updated: April 18, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017